March

March 23, 2020

NMPA: More Access to Increase Patient Samples in Clinical Trial

NMPA and National Health Commission jointly issued the Administrative Measures of Medical Device Expanded Access for Clinical Trial on March 20, implementing from the date of publication. The draft version […]
March 19, 2020

Guideline on AI Imaging Software for Coronavirus: Four Keywords to Keep in Mind

NMPA published the Review Points of CT Image-Assisted Triage and Evaluation Software for Coronavirus (COVID-19)-Infected Pneumonia on March 5, 2020. The document provides guidance to AI software manufacturers on the […]
March 18, 2020

NMPA Roundup February Coronavirus Special Issue

Amid the novel Coronavirus (COVID-19) outbreak, we deliver the Coronavirus Special Roundup to give you insights on the measures China NMPA has taken to handle its insufficient medical resources and […]
March 13, 2020

Practical Lessons for Coronavirus Related Products Fast Track Clearance in China

Wednesday, March 18, 2020 | 12:00 pm – 12:45 pm ETIn response to the Novel Coronavirus (COVID-19) outbreak, China regulatory agencies issued over 70 Emergency Approvals of medical devices, including diagnostic […]
March 10, 2020

Big Step! NMPA Streamlines Registration Procedure for Imported Devices!

NMPA published the Draft Document of “Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing” on March 5, 2020 for feedback. Feedbacks need to be submitted by March […]